Study on Ibrutinib, Rituximab, Venetoclax, and Chemotherapy for Newly Diagnosed Mantle Cell Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03710772

Provider View

This clinical trial is testing a combination of drugs, including ibrutinib, rituximab, venetoclax, and chemotherapy, to see how well they work together in treating patients who have just been diagnosed with mantle cell lymphoma.

Patient Parameters

Program Overview

The purpose of this study is to find out if a combination of drugs—ibrutinib, rituximab, venetoclax, and chemotherapy—can effectively treat patients with newly diagnosed mantle cell lymphoma. Ibrutinib may help stop cancer cells from growing by blocking certain enzymes. Rituximab is an antibody that may prevent cancer cells from growing and spreading. Venetoclax may block a protein that cancer cells need to survive. The chemotherapy drugs work in different ways to kill cancer cells or stop them from spreading. This study aims to see if using these drugs together is more effective than using them separately.

Description

Primary Objective:

  • To find out how many patients achieve a complete response to the treatment combination of ibrutinib and rituximab followed by venetoclax in newly diagnosed young patients with mantle cell lymphoma (MCL).

Secondary Objectives:

  • To assess the safety of the treatment combination of ibrutinib and rituximab followed by venetoclax in these patients.
  • To evaluate how long patients live without the disease getting worse and their overall survival time when treated with the combination of ibrutinib, rituximab, venetoclax, and chemotherapy.

Exploratory Objective:

  • To develop a new test for detecting minimal residual disease using a blood test that looks for tumor DNA in patients with MCL.

Study Outline:

Part I: Patients will take ibrutinib daily and receive rituximab through an IV on specific days during the first cycle and then on the first day of cycles 3 to 12. Venetoclax will be taken daily during cycles 5 to 12. Each cycle lasts 28 days, and treatment continues for up to 12 cycles unless the disease progresses or side effects become unacceptable.

Part II: Patients are divided into three groups based on their risk status:

  • Group I: Patients receive a combination of chemotherapy drugs and rituximab on specific days of each cycle. This treatment repeats every 28 days for up to 4 cycles. Afterward, they receive maintenance therapy with ibrutinib, venetoclax, and rituximab for up to 24 months.

  • Group II: Patients receive the same chemotherapy as Group I for up to 2 cycles, followed by the same maintenance therapy.

  • Group III: Patients receive only the maintenance therapy as in Group I.

After completing the study treatment, patients will have follow-up visits at 30 days, every 4 months for 2 years, every 6 months for another 2 years, and then annually for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of mantle cell lymphoma with CD20 positivity.
  • Must need treatment for mantle cell lymphoma due to symptoms or specific features like large tumors or high white blood cell count.
  • Newly diagnosed with no prior treatment for mantle cell lymphoma.
  • Must sign an informed consent form to participate in the study.
  • Must have measurable disease using scans or biopsies.
  • Must have a performance status score of 2 or less, indicating they are able to carry out daily activities.
  • Must have adequate blood cell counts and organ function as determined by specific tests.
  • Must not have other active cancers, except for certain skin cancers or other cancers in remission.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control during and after the study. Men must agree to use condoms and not donate sperm during and after the study.

Exclusion Criteria

  • Any serious medical condition that could increase risk or interfere with the study.
  • Pregnant or breastfeeding women.
  • Known HIV infection.
  • Active infections or other uncontrolled conditions.
  • Recent use of certain medications or foods that could interfere with the study drugs.
  • Active hepatitis B or C infection.
  • Significant nerve damage or gastrointestinal issues that could affect drug absorption.
  • Recent major surgery or need for certain medications that are not allowed in the study.
  • Heart conditions or recent heart attack.
  • Recent live vaccine administration.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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